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Novel cefmetazole compound and medicine composition thereof

A technology of cefmetazole sodium and cefmetazole, applied in the field of second-generation cephalosporin compounds and pharmaceutical compositions thereof, can solve the problems of increasing the chance of adverse reactions, reducing the content of cefmetazole sodium, increasing total impurities and the like

Active Publication Date: 2013-04-17
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Cefmetazole sodium is unstable to light and heat, and high temperature and humidity will cause chemical reactions such as oxidation and decomposition, which will reduce the content of cefmetazole sodium, increase the total impurities, and increase the chance of adverse reactions

Method used

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  • Novel cefmetazole compound and medicine composition thereof
  • Novel cefmetazole compound and medicine composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A pharmaceutical composition of cefmetazole sodium, the pharmaceutical composition is an injection, and the preparation method of the injection consists of the following steps:

[0026] (1) Dissolve 6g of cefmetazole sodium, 0.05g of mannitol, 0.2g of citrulline and 0.1g of sodium citrate in water for injection, add water to 1000ml, and stir well;

[0027] (2) Add activated carbon to the solution that has been stirred evenly in step (1), stir, adjust pH=6 with sodium hydroxide, decarburize and filter, filter through membrane, and fill;

[0028] (3) Rapidly cool down the solution filled in step (2) to freezing in a freeze dryer, maintain freezing at -40°C to -30°C for 3-5 hours, vacuumize, freeze and vacuum dry for 24 hours, vacuum press Plastic cap, rolled cap, obtains cefmetazole sodium injection.

Embodiment 2

[0030] A pharmaceutical composition of cefmetazole sodium, the pharmaceutical composition is an injection, and the preparation method of the injection consists of the following steps:

[0031] (1) Dissolve 8g of cefmetazole sodium, 0.2g of mannitol, 0.7g of citrulline and 0.5g of sodium citrate in water for injection, add water to 1000ml, and stir well;

[0032] (2) Add activated carbon to the solution that has been stirred evenly in step (1), stir, adjust pH=6 with sodium hydroxide, decarburize and filter, filter through membrane, and fill;

[0033] (3) Rapidly cool down the solution filled in step (2) to freezing in a freeze dryer, maintain freezing at -40°C to -30°C for 3-5 hours, vacuumize, freeze and vacuum dry for 24 hours, vacuum press Plastic cap, rolled cap, obtains cefmetazole sodium injection.

Embodiment 3

[0035] A pharmaceutical composition of cefmetazole sodium, the pharmaceutical composition is an injection, and the preparation method of the injection consists of the following steps:

[0036] (1) Dissolve 9g of cefmetazole sodium, 0.08g of mannitol, 0.5g of citrulline and 0.25g of sodium citrate in water for injection, add water to 1000ml, and stir well;

[0037] (2) Add activated carbon to the solution that has been stirred evenly in step (1), stir, adjust pH=6 with sodium hydroxide, decarburize and filter, filter through membrane, and fill;

[0038] (3) Rapidly cool down the solution filled in step (2) to freezing in a freeze dryer, maintain freezing at -40°C to -30°C for 3-5 hours, vacuumize, freeze and vacuum dry for 24 hours, vacuum press Plastic cap, rolled cap, obtains cefmetazole sodium injection.

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PUM

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Abstract

The invention discloses a novel cefmetazole compound, which has the purity greater than 99.5%. The invention further discloses a medicine composition of the cefmetazole compound. The medicine composition comprises the following components in part by weight: 60 to 90 parts of cefmetazole, 0.5 to 2 parts of mannitol, 2 to 7 parts of citrulline, and 1 to 5 parts of sodium citrate. The mannitol, the citrulline, and the sodium citrate contained in the medicine composition can work together to greatly improve light stability and heat stability of cefmetazole medicine composition, the cefmetazole medicine composition is less susceptible to oxygenolysis, and the probability of side effect of cefmetazole is effectively reduced.

Description

technical field [0001] The invention relates to a second-generation cephalosporin compound and its pharmaceutical composition, in particular to a novel cefmetazole sodium compound and its pharmaceutical composition. Background technique [0002] Cefmetazole sodium (Cefmetazole), also known as cyanazol-methoxycephalosporin, cefmetazol, vanguard dense forest, cefmethoxanazole, is a second-generation cephalosporin that is effective against broad-spectrum β-lactams produced by negative bacilli. The enzyme has good stability and is a broad-spectrum, high-efficiency, low-toxicity antibiotic. A large number of clinical trials have shown that cefmetazole sodium has good antibacterial activity against Gram-positive and negative bacteria, and also has good antibacterial activity against methicillin-resistant Staphylococcus aureus (MRSA), Bacteroides fragilis and anaerobic bacteria. It has strong tolerance and stability to various β-lactamases, good distribution in the body, and few a...

Claims

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Application Information

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IPC IPC(8): C07D501/57C07D501/12A61K31/546A61K47/10A61K47/18A61K47/12A61P31/04
Inventor 吴秋萍
Owner 石药集团中诺药业(石家庄)有限公司
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